VXRT Vaxart Inc.

7.89
-0.01  -0%
Previous Close 7.9
Open 7.76
52 Week Low 2.51
52 Week High 24.9
Market Cap $964,698,094
Shares 122,268,453
Float 121,554,202
Enterprise Value $789,631,933
Volume 4,855,346
Av. Daily Volume 22,513,404
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Norovirus vaccine (VXA-NVV-104)
Norovirus vaccine
Phase 1b
Phase 1b
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
VXA-CoV2-1
COVID-19 Vaccine
Phase 1
Phase 1
Phase 2 trial to commence mid-2021.
Universal Influenza vaccine
Universal Influenza vaccine
Phase 1
Phase 1
Universal influenza vaccine collaboration study with Janssen has been completed and a report is being compiled for Janssen.
BTA074 5% topical gel (teslexivir)
Condyloma
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., June 07, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that its executive officers, Andrei Floroiu, CEO, and Sean Tucker, CSO, are scheduled to present at the SVB Leerink CybeRx Series: Vaccine Forum on Monday, June 21, 2021 at 1:00 p.m. Eastern Time.        

    SVB Leerink CybeRx Series: Vaccine Forum
       
     Date:Monday, June 21st 2021
     Time:1:00 to 1:50 pm Eastern Time
     Presenters:Andrei Floroiu, President & CEO
      Sean Tucker, Founder & CSO

    Please contact your SVB Leerink representative to schedule virtual one-on-one meetings with Vaxart during the respective…

    SOUTH SAN FRANCISCO, Calif., June 07, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that its executive officers, Andrei Floroiu, CEO, and Sean Tucker, CSO, are scheduled to present at the SVB Leerink CybeRx Series: Vaccine Forum on Monday, June 21, 2021 at 1:00 p.m. Eastern Time.        

    SVB Leerink CybeRx Series: Vaccine Forum
       
     Date:Monday, June 21st 2021
     Time:1:00 to 1:50 pm Eastern Time
     Presenters:Andrei Floroiu, President & CEO
      Sean Tucker, Founder & CSO

    Please contact your SVB Leerink representative to schedule virtual one-on-one meetings with Vaxart during the respective conference.

    About CybeRx Series: Vaccine Forum

    The 2nd Annual CybeRx Series: Vaccine Forum will feature updates about COVID vaccine development, manufacturing and adoption.  The event will also feature companies and academic experts that will discuss the future of vaccines against other respiratory pathogens, including influenza, RSV, human metapneumovirus and para influenza.  Beyond these known pathogens, we will discuss preparedness for future pandemics, and emerging infectious disease risks such as noroviruses and tropical diseases such as chikungunya and zika, among others. 

    The CybeRx Series: Vaccine Forum will include research scientists from large and emerging companies, perspective from the U.S. Food and Drug Administration, and internationally recognized experts in the fields of virology and immunology.

    For further information, please visit: www.svbleerink.com

    About Vaxart

    Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

    Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," "plan" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates and clinical results and trial data (including its Phase 1b dose-ranging, repeat dose trial investigating its norovirus vaccine candidate (VXA-NVV-104) in elderly subjects); expectations regarding Vaxart's ability to develop effective vaccines against new and emerging variant strains; expectations regarding the timing and nature of future developments and announcements, including those related to trials and studies; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in humans or clinical trials; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.



    Contacts  
    Media Relations: Investor Relations:
    Gloria Gasaatura David R. Holmes
    LifeSci Communications LifeSci Advisors, LLC
    (646) 970-4688 (646) 970-4995


    Primary Logo

    View Full Article Hide Full Article
  2. SOUTH SAN FRANCISCO, Calif., May 27, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that Andrei Floroiu, CEO and Sean Tucker, CSO of the Vaxart executive team are scheduled to present at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 1:30 p.m. Eastern Time.        

    Jefferies Virtual Healthcare Conference

     Date:Friday, June 4th, 2021
     Time:1:30 to 1:55 pm Eastern Time
     Presenters:Andrei Floroiu, President & CEO
    Sean Tucker, Founder & CSO
     Webcast:https://wsw.com/webcast/jeff174/vxrt/1906092

    Please contact your Jefferies representative to schedule virtual one-on-one meetings…

    SOUTH SAN FRANCISCO, Calif., May 27, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that Andrei Floroiu, CEO and Sean Tucker, CSO of the Vaxart executive team are scheduled to present at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 1:30 p.m. Eastern Time.        

    Jefferies Virtual Healthcare Conference

     Date:Friday, June 4th, 2021
     Time:1:30 to 1:55 pm Eastern Time
     Presenters:Andrei Floroiu, President & CEO

    Sean Tucker, Founder & CSO

     Webcast:https://wsw.com/webcast/jeff174/vxrt/1906092

    Please contact your Jefferies representative to schedule virtual one-on-one meetings with Vaxart during the conference.

    About Jefferies Virtual Healthcare Conference

    The annual June conference will be held virtually with video fireside chats, presentations, keynotes, panels and 1x1/small group meetings via Zoom. 

    This virtual gathering of over 400 public & private healthcare companies and 3,000 leading executives, institutional investors, private equity investors & VCs will address near- and long-term investment opportunities and discuss the current trends driving healthcare in the U.S. and internationally.

    For further information, please visit: www.Jefferies.com

    About Vaxart

    Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

    Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," "plan" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates and clinical results and trial data (including its Phase 1b dose-ranging, repeat dose trial investigating its norovirus vaccine candidate (VXA-NVV-104) in elderly subjects); expectations regarding Vaxart's ability to develop effective vaccines against new and emerging variant strains; expectations regarding the timing and nature of future developments and announcements, including those related to trials and studies; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in humans or clinical trials; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

    Contacts 
      
    Media Relations:Investor Relations:
    Gloria GasaaturaDavid R. Holmes
    LifeSci CommunicationsLifeSci Advisors, LLC
    (646) 970- 4688(646) 970-4995






    Primary Logo

    View Full Article Hide Full Article
  3. Study will evaluate safety and immunogenicity of oral norovirus vaccine in elderly population

    Norovirus represents a significant unmet need in the elderly — there currently is no approved vaccine

    Safety and immunogenicity data to also inform oral COVID-19 vaccine program in older population

    SOUTH SAN FRANCISCO, Calif., May 07, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it has enrolled the first subject in a Phase 1b placebo-controlled, dose-ranging, repeat dose trial investigating its oral norovirus vaccine candidate in elderly subjects aged 55 – 80 years. This study is designed…

    Study will evaluate safety and immunogenicity of oral norovirus vaccine in elderly population

    Norovirus represents a significant unmet need in the elderly — there currently is no approved vaccine

    Safety and immunogenicity data to also inform oral COVID-19 vaccine program in older population

    SOUTH SAN FRANCISCO, Calif., May 07, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it has enrolled the first subject in a Phase 1b placebo-controlled, dose-ranging, repeat dose trial investigating its oral norovirus vaccine candidate in elderly subjects aged 55 – 80 years. This study is designed to evaluate the safety and immunogenicity of Vaxart's candidate, which is the only clinical stage norovirus oral tablet vaccine actively being developed.

    Norovirus is the leading cause of vomiting and diarrhea from acute gastroenteritis among people of all ages. In the United States, this virus contributes to 56,000 to 71,000 hospitalizations and 570 to 800 deaths annually.

    "Many think norovirus is just a virus that may infect those who go on cruises, when in fact it is a potentially fatal illness that affects around 20 million Americans every year, primarily young children or the elderly," said Andrei Floroiu, Vaxart's chief executive officer. "Norovirus is the most common viral cause of epidemic gastroenteritis and is a major public health problem with no approved vaccine available."

    In a health economic study published in The Journal of Infectious Diseases in July 2020, the negative economic impact of norovirus to the U.S. was estimated to be $10.5 billion annually. The burden of disease is concentrated in two groups: 1) approximately 7.5% of the population aged 65 and above are infected annually, with most hospitalizations occurring in this group; and 2) approximately 15% of children under age 5 are infected annually. The World Health Organization's (WHO) Product Development for Vaccines Advisory Committee has identified norovirus as a priority disease for vaccine development.

    "The norovirus program is part of our broader strategy to develop prophylactic vaccines that target a range of pathogens," Floroiu said. "We believe we have the capabilities to develop a new generation of orally administered vaccines, with the potential to benefit public health by protecting at-risk populations against infectious diseases."

    "Our norovirus vaccine candidate, developed using our proprietary oral tablet vaccine platform, is being evaluated in a comprehensive clinical program that is currently scheduled to include at least four clinical trials in 2021. These efforts put Vaxart at the forefront of norovirus research," said Dr. Sean Tucker, Vaxart's founder and chief science officer. "It is well-established that the elderly population is at a higher risk of infection and severe illness from norovirus. The vast majority of norovirus-associated deaths in the U.S. occur in patients aged 65 or over. This placebo-controlled, dose ranging study in older adults will help us understand safety and immunogenicity of the norovirus vaccine candidate in this population. Importantly, the results may give us insight as to what doses of our investigational COVID vaccine might be most effective in a dosing study of the elderly using our COVID-19 vaccine candidate."

    Norovirus is an enteric pathogen that infects epithelial cells of the small intestine. Vaxart's VP1- based bivalent oral tablet vaccine candidate targets the norovirus GI.1 Norwalk and GII.4 Sydney strains, which are the predominant strains affecting humans. Vaxart's oral tablet vaccine candidate is designed to produce antibodies against norovirus locally in the intestine.

    Vaxart has already performed and reported on three previous clinical trials with a norovirus vaccine candidate:

    • In a Phase 1 bivalent study the vaccine showed no interference with the monovalent arms of the study performing as well as the bivalent arm.



      • The study met all primary endpoints for safety and demonstrated robust immunogenicity, with 78% - 93% of subjects responding by eliciting IgA antibody secreting cells, a key marker for mucosal immunity and a potential correlate of protection for norovirus disease.

    • In an earlier Phase 1 monovalent study more than 80% of recipients of the high dose vaccine developed mucosally-primed norovirus specific circulating antibody secreting cells, IgA memory and effector B cells expressing the α4β7 gut homing receptor, and a greater than tenfold increase in fecal IgA antibodies.

    • In the high dose group of another Phase 1 dose optimization monovalent study, 100 percent of adults responded as measured by a significant increase in IgA and IgG antibody secreting cells after 2 doses.

    The dose ranging trial in the elderly is the third of four Vaxart norovirus trials that are being conducted currently or are planned for 2021. Vaxart currently is administering a second booster dose to a subset of subjects who had participated in the prior Phase 1b bivalent study and recently began a study designed to evaluate different boosting regimens.

    Vaxart also expects to launch a Phase 2 norovirus human challenge study later this year.

    VXA-NVV-104 Phase 1b Trial Design

    The Phase 1b study is designed to enroll 48 subjects aged 55 to 80 years old. Subjects will be randomized into two cohorts stratified by age: Cohort 1 will receive either low dose vaccine candidate (1e10 I.U. n=16) or placebo (n=8); Cohort 2 will receive high dose vaccine candidate (1e11 I.U. n=16) or placebo (n=8). The study drug will be an oral tablet administered on Days 1 and 29. The endpoints are safety and immunogenicity. For more information, refer to ClinicalTrials.gov. (NCT04854746).

    About Vaxart

    Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

    Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," "plan" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates and clinical results and trial data (including its Phase 1b dose-ranging, repeat dose trial investigating its norovirus vaccine candidate (VXA-NVV-104) in elderly subjects); expectations regarding Vaxart's ability to develop effective vaccines against new and emerging variant strains; expectations regarding the timing and nature of future developments and announcements, including those related to trials and studies; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in humans or clinical trials; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

    Contacts 
    Media Relations:Investor Relations:
    Gloria GasaaturaDavid R. Holmes
    LifeSci CommunicationsLifeSci Advisors, LLC
    (646) 970- 4688(646) 970-4995

     



    Primary Logo

    View Full Article Hide Full Article
  4. Study will evaluate safety and immunogenicity of multiple distinct dosing regimens of norovirus oral vaccine candidate

    Norovirus infects 15% of U.S. children under age five every year

    Study results may inform the COVID-19 oral vaccine program

    SOUTH SAN FRANCISCO, Calif., May 04, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it has enrolled the first subject in a Phase 1b boosting regimen trial of its norovirus vaccine candidate. This study is designed to evaluate the safety and immunogenicity of various dosing intervals for Vaxart's candidate, which is the only clinical stage…

    Study will evaluate safety and immunogenicity of multiple distinct dosing regimens of norovirus oral vaccine candidate

    Norovirus infects 15% of U.S. children under age five every year

    Study results may inform the COVID-19 oral vaccine program

    SOUTH SAN FRANCISCO, Calif., May 04, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it has enrolled the first subject in a Phase 1b boosting regimen trial of its norovirus vaccine candidate. This study is designed to evaluate the safety and immunogenicity of various dosing intervals for Vaxart's candidate, which is the only clinical stage norovirus oral tablet vaccine actively being developed.

    In a health economic study published in the American Journal of Preventative Medicine in January 2021, the negative economic impact to the U.S. of norovirus was estimated to be approximately $10.5 billion* annually. Annual vaccine costs with an efficacy of 75% were cost effective and cost saving at ≤$1,600 and ≤$1,300 per year, respectively, for preschool-aged children, and ≤$165 and ≤$100 per year, respectively, for older adults.

    "Norovirus is a potentially fatal illness that affects around 20 million Americans annually. It has an enormous impact on young families with 15% of children under age five being infected every year in the United States," said Andrei Floroiu, Vaxart's chief executive officer. "The WHO designated norovirus as a priority disease for vaccine development, as it is a major public health problem with no approved vaccine available, having a multi-billion dollar annual impact in the US alone and significantly more globally."

    Sean Tucker, Ph.D., chief scientific officer of Vaxart commented, "This study will provide insight into the optimal booster timing to maximize immunogenicity and total response of our oral norovirus vaccine candidate. Additionally, the findings may provide important information into the overall dynamics of our platform technology that could guide future protocols for our other vaccine candidates, including our oral COVID-19 tablet vaccine candidate, which is estimated to enter Phase 2 clinical trials around mid-year."

    Norovirus is an enteric pathogen that infects epithelial cells of the small intestine. Vaxart's VP1-based bivalent oral tablet vaccine candidate targets the norovirus GI.1 Norwalk and GII.4 Sydney strains, which are the predominant strains affecting humans.

    The booster regimen trial is the second of four Vaxart norovirus trials that are ongoing or are planned for 2021. Vaxart is currently administering a second booster dose to a subset of subjects who had participated in the prior Phase 1b bivalent study. The Company is also scheduled to initiate an age escalation trial in subjects over 65 years old and plans to launch a Phase 2 challenge study later this year.

    VXA-NVV-105 Phase Booster Regimen 1b Trial Design

    The Phase 1b study is designed to enroll 30 subjects aged 18 to 55 years old. Subjects will be randomized into 3 cohorts: Cohort 1 will receive the vaccine candidate on day 1 and week 4 of the study; Cohort 2 will receive the vaccine candidate on day 1 and week 8 of the study; Cohort 3 will receive the vaccine candidate on day 1 and week 12 of the study. The endpoints are safety and immunogenicity. For more information, refer to ClinicalTrials.gov.

    * Note: The $10.5 Billion annual economic impact of norovirus infections in the US includes both direct medical costs and indirect costs such as time off work, school, etc.

    About Vaxart

    Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the Company to develop oral analogs of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

    Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," "plan" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates and clinical results and trial data, potential insights from Vaxart's Phase 1b norovirus study, the potential role of Vaxart's platform technology expectations regarding the timing and nature of future developments and announcements, including those related to trials and studies; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in humans or clinical trials; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

    Contacts



     
    Media Relations:

    Gloria Gasaatura

    LifeSci Communications

    (646) 970- 4688



    Investor Relations:

    David R. Holmes

    LifeSci Advisors, LLC

    (646) 970-4995



    Primary Logo

    View Full Article Hide Full Article
  5. Vaxart oral vaccine induced higher CD8+ T-Cell responses than those seen with Moderna or Pfizer vaccines in comparative experiment conducted by the Company

    IgA antibodies triggered in the mucosa, show broad cross-reactivity

    SOUTH SAN FRANCISCO, Calif., May 03, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced today at Vaxart's key opinion leader event that new data obtained from its Phase I COVID-19 trial added to the evidence suggesting that VXA-CoV2-1, the company's first COVID-19 oral vaccine construct that triggers mucosal immunity and includes both the S and the N SARS-Cov-2 proteins, has…

    Vaxart oral vaccine induced higher CD8+ T-Cell responses than those seen with Moderna or Pfizer vaccines in comparative experiment conducted by the Company

    IgA antibodies triggered in the mucosa, show broad cross-reactivity

    SOUTH SAN FRANCISCO, Calif., May 03, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced today at Vaxart's key opinion leader event that new data obtained from its Phase I COVID-19 trial added to the evidence suggesting that VXA-CoV2-1, the company's first COVID-19 oral vaccine construct that triggers mucosal immunity and includes both the S and the N SARS-Cov-2 proteins, has broad cross-coronavirus activity.

    "We have previously announced study data showing that our oral vaccine could be as protective as the leading injectable against flu, and that it does so by triggering a very different immune response. Data obtained from the Phase I study were compared to data from volunteers subsequently vaccinated with the Moderna or Pfizer mRNA vaccine distributed under emergency use authorizations (EUAs) and suggest that the same may be true against coronavirus. Our vaccine's immune response appears very different that that seen from the leading injectables: mucosal antibodies rather than serum antibodies, and more potent T-cell responses," said Andrei Floroiu, Vaxart's chief executive officer. "For our first oral COVID-19 vaccine candidate, we believe that these differences in immunogenicity profile may have a benefit in cross-reactive protection."  

    The Phase I open-label study is intended to evaluate the safety and immunogenicity of Vaxart's vaccine candidate. Data obtained from Vaxart's oral COVID-19 vaccine Phase I trial showed substantial CD8+ T-cell responses, as measured by IFN-g and TNF-a induction. In a comparative experiment conducted by Vaxart, Phase I study data was compared to T-cell responses from volunteers subsequently vaccinated with the Moderna or Pfizer mRNA vaccine, indicating the mRNA vaccines induced fewer T-cell responses.

    "We measured the T-cell responses in 9 volunteers vaccinated with the mRNA vaccines under EUAs and compared them in the same assays at the same timepoints to T-cell responses induced in subjects participating in our clinical trial (N=26 paired samples, or N=7 in the sub-study). Our vaccine appeared to produce CD8+ T-cell responses of a higher magnitude," said Dr. Sean Tucker, chief scientific officer at Vaxart. "CD8+ T-cells produced by our vaccine can recognize and are capable of destroying cells infected with the virus, including in the mucosa. If you are effective at killing the virus-infected cells in the upper respiratory tract, you may be more likely to recover quicker or have a very mild course of infection," he said. "The strength of T-cell responses against both S and N proteins, which we targeted, leads us to believe that VXA-CoV2-1 offers a promising solution to variants."

    In his presentation, Dr. Tucker discussed:

    • Vaxart's vaccine candidate showed higher CD8+ T-cell responses than the Pfizer and Moderna vaccines
    • Higher T-cell responses correlated to protection against COVID disease in a prospective Phase I study of first responders
    • The Vaxart vaccine candidate elicited a T cell response against SARS-Cov-2, as well as showed cross-reactivity against diverse endemic coronaviruses such as 229E, NL63, HKU1, and OC43      
    • N protein responses to SARS-CoV-1 have been shown to last 17 years after infection and cross-react to SARS-CoV-2
    • Vaxart's vaccine candidate triggered specific IgA antibodies in the mucosa. These mucosal IgA responses appeared to be cross-reactive against other coronaviruses such as SARS-CoV-1, MERS, and the endemic common cold viruses 229E, NL63, HKU1, and OC43

    About Vaxart

    Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication. Vaxart has filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

    Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans, and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates and clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations relating to Vaxart's relationship with Emergent BioSolutions, Inc., Kindred Biosciences and Attwill Medical Solutions Sterilflow, LP, including their ability to produce cGMP vaccines and the timing thereof; Vaxart's expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for coronaviruses such as SARS, MERS and SARS-CoV-2; expectations regarding Vaxart's ability to develop effective vaccines against new and emerging variant strains; expectations regarding the timing and nature of future developments and announcements, including those related to trials and studies; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in humans or clinical trials; the expected role of mucosal immunity in blocking transmission of COVID-19; and Vaxart's expectations with respect to the effectiveness of its product candidates, including Vaxart's potential role in mitigating the impact of COVID-19. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical , regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

    Contacts  
       
    Brant Biehn Vaxart, Inc.

    650 550 3500      



     David R. Holmes LifeSci Advisors, LLC

    646 970 4995





    Primary Logo

    View Full Article Hide Full Article
View All Vaxart Inc. News